Drug

Novo Nordisk's Once-Weekly Sogroya Wins Positive CHMP Opinion for Children with Idiopathic Short Stature – Long-Acting Growth Hormone Set to Expand Beyond GHD in Europe
Market approval filingsNovo Nordisk

Novo Nordisk’s Once-Weekly Sogroya Wins Positive CHMP Opinion for Children with Idiopathic Short Stature – Long-Acting Growth Hormone Set to Expand Beyond GHD in Europe

Novo Nordisk A/S (NYSE: NVO) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending…

BioMarin's Vosoritide Wins NMPA Approval in China – First CNP-Analog Therapy for Pediatric Achondroplasia Enters the World's Largest Rare Bone Disease Market

BioMarin’s Vosoritide Wins NMPA Approval in China – First CNP-Analog Therapy for Pediatric Achondroplasia Enters the World’s Largest Rare Bone Disease Market

Alexion's Klygefa Recommended for EU Approval in AChR-Positive Generalized Myasthenia Gravis – AstraZeneca's Subcutaneous Nanobody C5 Inhibitor Clears Major Regulatory Hurdle

Alexion’s Klygefa Recommended for EU Approval in AChR-Positive Generalized Myasthenia Gravis – AstraZeneca’s Subcutaneous Nanobody C5 Inhibitor Clears Major Regulatory Hurdle

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TransThera Sciences' YOCHANRA (Tinengotinib) Receives First Prescription in China – World's First Approved Targeted Therapy for Post‑FGFR‑Inhibitor Cholangiocarcinoma
Market launchTransThera Sciences

TransThera Sciences’ YOCHANRA (Tinengotinib) Receives First Prescription in China – World’s First Approved Targeted Therapy for Post‑FGFR‑Inhibitor Cholangiocarcinoma

Haisco's HSK42360‑Na Proposed for CDE Breakthrough Therapy Designation – Next‑Generation BRAF Inhibitor Targets V600‑Mutant High‑Grade Glioma
Breakthrough therapyHaisco Pharmaceutical

Haisco’s HSK42360‑Na Proposed for CDE Breakthrough Therapy Designation – Next‑Generation BRAF Inhibitor Targets V600‑Mutant High‑Grade Glioma

Astellas' PADCEV Plus Keytruda Receives Positive CHMP Opinion – Perioperative Muscle‑Invasive Bladder Cancer Regimen Nears EU Approval
ADC / XDCAstellas Pharma

Astellas’ PADCEV Plus Keytruda Receives Positive CHMP Opinion – Perioperative Muscle‑Invasive Bladder Cancer Regimen Nears EU Approval

Novo Nordisk's FREHEMGO (Denecimig) Receives Positive CHMP Opinion – Next‑Generation Hemophilia A Prophylaxis Nears EU Authorization
Novo NordiskNYSE: NVO

Novo Nordisk’s FREHEMGO (Denecimig) Receives Positive CHMP Opinion – Next‑Generation Hemophilia A Prophylaxis Nears EU Authorization

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